Hyperfine, Inc.

Good afternoon and welcome to the Hyperfine Quarter 1, 2026 earnings call. I am Franz and I'll be the operator assisting you today. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star one on your telephone keypad. If you would like to redraw your question, Press star one again. Thank you. I would now like to turn the call over to Webb Campbell with Gilmartin Group. Please go ahead.

Thank you for joining today's call. Earlier today, Hyperfine Inc. released financial results for the quarter ended March 31st, 2026. A copy of the press release is available on the company's website as well as sec.gov. Before we begin, I'd like to remind you that management will make statements during this call that include forward-looking statements within the meaning of the federal securities laws and made pursuant to the safe harbor provision of the Private Securities Litigation Reform Act of 1995. Any statements contained in this call that relate to expectations or predictions of future events, results, or performance are forward-looking statements. All forward-looking statements, including without limitation, those relating to our operating trends and future financial performance, expense management, market opportunity, commercial and international expansion, regulatory approvals, and product development are based upon our current estimates and various assumptions. These statements involve material risks and uncertainties that could cause actual results or events to materially differ from those anticipated or implied by these forward-looking statements. Accordingly, you should not place undue reliance on these statements. For a list and description of these risks and uncertainties associated with our business, please refer to the risk factors section of our latest periodic filing with the Security and Exchange Commission. This conference call contains time-sensitive information and is accurate only as of today's live broadcast. Hyperfine Inc. disclaims any intention or obligation, except as required by law, to update or revise any financial projections or forward-looking statements, whether because of new information, future events, or otherwise. With that, I will turn the call over to Maria Sainz, President and Chief Executive Officer.

Good afternoon, and thank you for joining us. On the call with me today is our Chief Administrative Officer and Chief Financial Officer, Brett Hadle. The first quarter was a strong start to 2026 as we executed across our commercial and financial priorities. We delivered revenue of $3.9 million, our second highest quarter ever, up 83% year over year. Q1 was our third full quarter, selling our next generation subsystem in the U.S. market and selling into our new neurology office business. We posted a 51% gross margin and demonstrated operating leverage and spending discipline closing the quarter with a strong balance sheet. We also achieved several important milestones. We obtained CE and UKCA marks for the next generation subsystem and our advanced DWI Optive AI software. We significantly increased enrollment in our contrast PMR study and now sit at over 50% of our enrollment goal. We launched our advanced DWI Optive AI software at the 2026 International Stroke Conference supported by a paper published in SIN demonstrating the subsystem's enhanced stroke detection capabilities. And lastly, we saw compelling data from our neuro PMR study presented at the American Society of Neuroimaging highlighting broad clinical utility high diagnostic value, and a strong patient preference with the subsystem in neurology offices. With our strong execution in the first quarter across revenue growth margin, cash burn, and milestones, we are reiterating our guidance to deliver transformative growth, healthy margin expansion, and lower cash burn for hyperfine in 2026. Commercially, Demand for the next generation subsystem remains strong, and we continue to diversify revenue across our three business verticals. Hospitals, including health systems, neurology offices, and international markets. I will now walk through updates from our three business verticals in more detail. In our hospital business, we're driving sales of our next generation subsystem with high interest from adult and pediatric critical care and emergency departments. We are also leveraging positive clinical and economic impact data from early adopters to expand our footprint and increase utilization across sites of care in the hospital. Programs launched since the introduction of our next generation system have demonstrated high utilization and positive clinical and economic outcomes. Strengthening our full hold in the hospital, at the International Stroke Conference in February, we launched our Advanced DWI Optive AI software, extending our value in stroke workflows to the ED and across hub and spoke networks. The Advanced DWI Optive AI software is now implemented in most scanners across our installed base. We continue to advance our health system and IDN strategy and are seeing repeat sales within IDNs across multiple sites over the last couple quarters. Our pipeline continues to shift towards multi-unit and IDN opportunities. The leverage from selling into IDNs is a key part of our strategy to drive adoption of our technology across hospitals. These strategic accounts represent attractive expansion opportunities that have longer sales cycles with additional system-wide stakeholders and steps in their procurement processes. In our office business, placements were a solid contributor to our revenue performance this quarter And following strong exposure and market activation work at the American Society of Neuroimaging and Neuronet meetings in Q1, we have had mostly next-generation sleep system placements in larger offices. We continue to build a healthy pipeline across practices of varying sizes. Also, during the first quarter, data from NeuroPMR was presented at the American Academy of Neuroimaging. In neurology offices for neuro-PMR, the subsystem was used for patients across several neurological conditions, including headaches, dementia, multiple sclerosis follow-up, and tumor follow-up. The study shows the high diagnostic value of the subsystem in this setting, and the patient experience with the subsystem was rated very favorably compared to conventional MRI. Turning to our international business, in Europe, our Optiv AI software was launched during the quarter and is seeing strong reception. In India, the first Duke system is now live in clinical use at a leading KOL center in Delhi through our distribution partner. Additionally, we're very excited to have received CE and UKCA marks for our next generation subsystem with the latest version of Optiv AI software. We're working to complete all translations and documentation processes to be in a position to launch in Europe in the third quarter. This has positioned us for a stronger second half of 2026 international. Looking ahead, we remain committed to increasing the clinical value of the subsystem through technology, innovation, and clinical evidence. We plan on introducing the next software upgrade with additional improvements in image quality and clinical capabilities by the end of 2026. Driven by clinician interest, we are also evaluating and conducting pilot activities in new sites of care for our subsystem. namely the use of the subsystem in the operating room or angiosuite to support timely scanning of patients following procedures, as well as the use of the subsystem on mobile units for community-based brain screening programs. Finally, I would like to provide an update on our contrast PMR study. I'm happy to share that enrollment is progressing well with three study sites now active and enrollment over 50% of target. Over the long term, we believe expanding the subsystem indications for use to include contrast is of value in all types of care as it drives increased clinical utility. Brain scans with contrast represent a meaningful percentage of all brain MRIs. As a reminder, The contrast PMR study is a prospective multicenter clinical study designed to evaluate the feasibility and visualization benefits of contrast-enhanced ultra-low-field portable MRI. We currently expect the study to support a potential FDA submission by the end of 2026 to expand the subsystems intended use to include gadolinium-based contrast agents. Also, a contrast indication can further support the office opportunity as cases in offices are all elective and use CPT codes for reimbursement. As a reminder, brain MRI exams with contrast are reimbursed using a dedicated CPT code 70553. And very pleased with the strong market traction we continue to generate and the level of image quality the subsystem provides. I'm proud of the Hyperfine team's execution, not only in the last quarter, but over the last two years, delivering numerous milestones to get to this point. We continue to see our business progressively strengthening through the year, and I remain confident in our commercial traction, pipeline, and opportunity. With that, I will turn the call over to Brett to review our financial performance and guidance.